Protocol/serial number

Study information

Scientific title

Acronym

PROMS

Study hypothesis

The aim of this study to explore whether patients are willing and able to complete questionnaires to asses quality of life on a tablet computer, so that the information is entered electronically by the patient.

Ethics approval

South Central- Hampshire A, 05/07/2016, ref: 16/SC/0289

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

See additional files

Condition

Intervention

Participants will be asked to complete questionnaires relating to quality of life on a tablet computer – EORTC QLQ C30 (generic quality of life), EORTC PR25 (Prostate cancer specific module) and EQ-5D-5L (brief quality of life scale used to calculate QALYs).

Visit 1 takes place before commencing treatment and takes place either in clinic or at first treatment appointment. Meet Research Fellow and complete informed consent. Research fellow to complete demographics and “computer familiarity” questionnaires (paper). Participant to complete QoL questionnaires on tablet computer with support from Research Fellow if needed. Research fellow to complete “feasibility” paper questionnaires.

Visit 2 takes place 3 months from the start of treatment, and involves either an in clinic or at treatment appointment (meet research fellow and complete QoL questionnaires as above on tablet. Research fellow to complete feasibility questionnaire) or for the participant to complete questionnaires at home following an email reminder (esearch fellow to complete feasibility questionnaire either in person (at clinic or treatment appointment) or by phone).

Optional remote completionAt 1 and 2 months from start of treatment participants complete QoL questionnaires at home – following email reminder – either on desktop/laptop via web-based interface or on a mobile phone/tablet on an app.

Total duration of intervention = 3 months, no study follow-up beyond that date.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Feasibility will be assessed by measuring the time taken to complete the questionnaire (collected by electronic data collection system), patient reported feasibility (via feasibility questionnaire) and support needed from the researcher (via feasibility questionnaire) at baseline and 3 months, and measuring the rate of questionnaire completion at 3 months.

Secondary outcome measures

1. Health care professional reported feasibility (all clinic staff including recruiting oncologists) is measured via a HCP feasibility questionnaire at the end of the study2. Uptake rate (impressions from recruiting doctors( is obtained from HCP feasibility questionnaire at the end of the study3. Comparison with clinical decision at 3 months is assessed via comparison with decision whether or not to continue treatment and PSA measurement4. Suitability of tools (sensitivity of tools to change in QoL) is measured via comparison between tools